IndiaCLEN Multicentre Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children (ISPOT)
Pneumonia
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring Efficacy of Treatment, Severe, home treatment, treatment at hospital
Eligibility Criteria
Inclusion Criteria:
- Children aged 3 to 59 months with pneumonia and lower chest wall indrawing
- Ability to take orally
- Absence of radiological consolidation or effusion
- Informed consent by a legal guardian
Exclusion Criteria:
Children with any of the following conditions:
- Very severe pneumonia/disease
- Respiratory rate > 70/min
- Persistent vomiting
- Known prior episodes of asthma, or, three or more prior episodes of wheezing
- LCI that resolves after three doses of bronchodilator therapy1
- Documented use of prior oral antibiotics for 48 hours
- Severe malnutrition (weight for height < 3SD or kwashiorkor)
- Known penicillin or amoxicillin allergy
- Hospitalization in the last two weeks
- Known or clinically recognizable HIV, congenital cardiac or respiratory anomalies, chronic lung disease including bronchopulmonary dysplasia, neurological impairment that affects respiratory function, renal diseases, malignant or haematological diseases.
- Other diseases requiring antibiotic therapy at presentation, such as meningitis,dysentery, osteomyelitis, septic arthritis, evident tuberculosis, etc.
- Anaemia requiring blood transfusion
- Kerosene poisoning
- Measles in the last 15 days
- Previous inclusion in the study or already included in another study
- Living outside a pre-defined area
- Parental or caretaker refusal to participate in the study
Sites / Locations
- Indira Gandhi Govt. Medical College, Nagpur
- B.J. Medical College, Pune
- Mahatma Gandhi Institute of Medical Sciences, Sevagram
- Institute of Child Health, Chennai
- Jawaharlal Nehru Medical College, Aligarh Muslim University
- Post Graduate Institute of Medical Sciences, Chandigarh
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Severe Pneumonia - Hospital Management
Severe Pneumonia - Home Management
Those randomized to hospital management will be monitored by health personnel for at least 48 hours for clinical deterioration and parameters like temperature, Respiratory rate, Lower chest indrawing, Pulse rate, Clinical deterioration, Other signs eg. comorbid conditions, Assessment of adherence, Adverse event. Mothers, whose children are discharged after 48 hours, will be counseled to continue with oral treatment prescribed for a period of 7 days and will be advised to return to healthcare facility at their scheduled times and any time during the study period if there is clinical deterioration. The symptoms and signs of clinical deterioration will be discussed with the mother as described in the "patient discharge counselling checklist". Mothers will be given a "study patient data card"
For those randomized to home management, first dose will be administered by the mother/caretaker under supervision at health facility. The health personnel will assess the parameters like temperature, Respiratory rate, Lower chest indrawing, Pulse rate, clinical deterioration, Other signs eg. co-morbid conditions, Assessment of adherence, Adverse event when they visit the home after 24 hours, 72 hours and on day 8th. Mothers will be advised to return to the healthcare facility at their scheduled times and any time during the study period if there is clinical deterioration. The symptoms and signs of clinical deterioration will be discussed with the mother as described in the "patient discharge counselling checklist". Mothers will be given a "study patient data card" with contact Numbers.